WO2021250703A1 - Soutien-gorge - Google Patents

Soutien-gorge Download PDF

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Publication number
WO2021250703A1
WO2021250703A1 PCT/IN2021/050568 IN2021050568W WO2021250703A1 WO 2021250703 A1 WO2021250703 A1 WO 2021250703A1 IN 2021050568 W IN2021050568 W IN 2021050568W WO 2021250703 A1 WO2021250703 A1 WO 2021250703A1
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WO
WIPO (PCT)
Prior art keywords
breast
bra
wearer
pressure
post
Prior art date
Application number
PCT/IN2021/050568
Other languages
English (en)
Inventor
Venetia DICKINSON
Atul GAUR
Original Assignee
GB Medical and Accessories Limited
PATEL, Trupti
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by GB Medical and Accessories Limited, PATEL, Trupti filed Critical GB Medical and Accessories Limited
Publication of WO2021250703A1 publication Critical patent/WO2021250703A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41C—CORSETS; BRASSIERES
    • A41C3/00—Brassieres
    • A41C3/005—Brassieres specially adapted for specific purposes
    • A41C3/0057—Brassieres specially adapted for specific purposes for sport activities
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41C—CORSETS; BRASSIERES
    • A41C3/00—Brassieres
    • A41C3/005—Brassieres specially adapted for specific purposes
    • A41C3/0064—Brassieres specially adapted for specific purposes for medical use or surgery
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41C—CORSETS; BRASSIERES
    • A41C3/00—Brassieres
    • A41C3/12—Component parts
    • A41C3/14—Stiffening or bust-forming inserts

Definitions

  • the invention relates to a bra, and in particular to a bra for sports or post-surgical use comprising a means of applying support to the breast.
  • the breasts are located on the anterior aspect of the chest wall.
  • the breast tissue is situated within the superficial layer of the thoracic wall, anterior to the pectoralis muscles.
  • Breast mass is primarily composed of subcutaneous tissue, and corpus mammae is composed of two subcomponents - the stroma and the parenchyma.
  • the connective tissue in the stroma, the Cooper’s ligaments provides suspensory support to the breast.
  • the support provided is limited, and as a result the breasts are able to move over the chest wall, primarily as a result of movement or motion of the body. Such movement can cause discomfort when excessive, particularly during exercise.
  • a bra is worn to support and limit such movements of the breast.
  • a standard bra comprises of two cups containing an underwire which supports the Cooper’s ligaments and help overcome the weight of breast.
  • underwiring or the sole use of this underwiring, is not good enough, especially in a sports or post-surgical bra, for comfort reasons.
  • the cups of a standard bra provide very little support to the breast tissue.
  • Sports bras are typically designed to limit movement of the breasts resulting from sporting activity either by compression or reshaping the cups and/or adding extra straps. Breasts move anywhere from 4 cm to 15 cm or so during activities, such as walking, running etc. The support provided by currently available sports bra may not consider and/ or compensate for the dynamics of such movements, and for the forces acting on the breast tissue during sport activity. Failure to stabilize the breasts, and in particular to counter the forces applied to the breasts as a result of movement, can cause pain, discomfort and even injury.
  • bras play an important role after breast surgery in women.
  • Over 3 million surgical breast procedures were carried out in 2017. This includes surgeries carried out for (a) cosmetic reasons, such as mastopexy, augmentation mammoplasty and breast reduction surgery; and for (b) medical reasons, including surgery for breast cancer and breast abscesses, lumpectomy, breast biopsy, microductectomy, wide local excisions and mastectomy, which may or may not be followed by autologous or implant reconstruction surgery.
  • bras typically fail to provide optimal support needed to reduce breast tissue tension, and to enhance comfort of the breast, in post surgery period.
  • the wound area and surrounding body parts both should be well supported to provide comfort and promote healing.
  • a lack of support can result in complications such as wound dehiscence, tension, pain, and discomfort.
  • the implant With implant- based reconstructions, the implant can rotate or displace without a proper support to keep it aligned and in place.
  • Such complications often lead to additional surgical procedure(s) which increases the healthcare costs, and can also be emotionally challenging besides causing pain and discomfort, to the patient.
  • Simple adhesive gauze-like dressings which are in common use, do not provide the much desired support.
  • pressure application has been shown to stimulate tissue granulation and progressive wound closure. It aids with exudate removal, reduces tissue swelling, and increases blood supply to the wound site. Having said that too much tension on a wound can be harmful as it can cause the wound to give way or rupture at a suture line, and can lead to a bad scar in extreme cases.
  • a further complicating factor in breast surgery is that many incisions are below the nipple, where the weight of the breast causes wound tension to increase to the point that the weight of the breast itself causes the wound to remain open by pulling the wound site apart.
  • a typical sports bra is not adjustable to any significant extent to help with above challenges. This can be problematic, especially in post-surgical situations, as the breast can be swollen after the surgery, which may be variable i.e. with time swelling may go up or down. Hence a typical sports bra fitted in immediately post-surgery may become loose (or tight), and thus fails to provide the desired support. Further, whilst a sports bra typically provides a generalised compressive force over the area in contact with the skin, it does not provide support in any specific or desired direction to the breast tissue.
  • Post-surgical bras are known.
  • US 6135975 discloses a garment comprising a stretchable material band which extends around the back of the patient and two non- stretchable panels at the front that support and significantly immobilise the patient’s side and breast tissue.
  • the garment closes at the front via a VelcroTM patch, allowing some adjustability along with VelcroTM adjustable straps to relieve pressure on the shoulders.
  • the garment is intended primarily for use after chest surgery with aims to minimise the stress on the sutured incision line at the centre of the patient to allow the incision to heal.
  • AU 2014213512 innovation is concerned with a bra which incorporates a means of applying reduced pressure to the breast area. It is intended for use on necrotic wounds rather than for general use and is said to aid healing by removing exudate from the wound.
  • the bra comprises an elastic dressing material shaped to the breast area and clasped at the back, which is sealed around the edges thereby holding the dressing to the breast area.
  • a negative pressure device such as the PicoTM is attached to the bra and adheres to the skin via adhesive tape.
  • Such negative wound pressure devices require an air tight seal with the skin, and given the location of the wound site following breast surgery, such seals are hard to achieve and maintain and may not be comfortable. This can particularly be the case as the wound physiology changes over time.
  • GB2551534 discloses a bra for use during radiotherapy which comprises inflatable bladders.
  • the purpose of these bladders is to move the untreated breast away from the breast to be treated, in order to reduce the radiation hazard.
  • Such a system can increase (rather than reducing) strain and tension on breast tissue.
  • a sports or post-surgical bra comprising: a first section, for location over a left breast of a wearer; a second section, for location over a right breast of the wearer; a first band, for location around the torso of the wearer, the first band extending from an outer side of the first section to an outer side of the second section; an insert comprising an inflatable or inflated body, wherein the body is inflated, or configured to inflate to a positive pressure; a fastener which secures, or is configured to secure, the insert in a position such that in use the insert applies pressure to a breast of the wearer, and/or displaces a volume thereof, to counter one or more forces acting on the breast tissue.
  • the insert counters the one or more forces acting on the breast tissue, and can provide comfort and aid in healing time for a post-surgical patient.
  • the first section may be connected directly to the second section.
  • the bra may comprise a second band, for location between the breasts of the wearer, extending from an inner side of the first section to an inner side of the second section.
  • the first section may define a first cup.
  • the second section may define a second cup.
  • the first band may be a continuous band.
  • the second band may be a continuous band. Accordingly, the first and/ or second band may comprise an elasticated material to aid a wearer when donning and removing the bra.
  • the bra comprises a fastening mechanism comprising first and second parts configured to reversibly connect to each other, whereby a wearer may don or remove the bra when the first and second parts are not attached and the bra is held in place on a wearer when the first and second parts are attached.
  • the first and/or second band comprises a first panel, a second panel and the fastening mechanism is configured to reversibly connect the first and second panels together.
  • the fastening mechanism is disposed between the first and second sections on the front of the bra.
  • the front of the bra maybe understood to be the section adjacent to a wearer’s front in use.
  • the fastening mechanism may be connected directly to the first and second sections.
  • the second band may comprise a first panel, a second panel and the fastening mechanism configured to reversibly connect the first and second panels together.
  • the first band may comprise a first panel, a second panel and the fastening mechanism configured to reversibly connect the first and second panels together.
  • the fastening mechanism may be disposed on the back of the bra.
  • the back of the bra may be understood to be the section adjacent to a wearer’s back in use.
  • the fastening mechanism may comprise a first part and a second part, wherein the first and second parts are configured to reversibly engage.
  • the fastening mechanism may comprise a hook and eye fastener, a zip, hook and loop fastenings (e.g. VelcroTM), magnets or a digitally controlled mechanism.
  • the fastening mechanism is configured to allow a wearer to selectively increase or decrease a circumference of the bra.
  • the first part of the fastening mechanism may comprise a hook and the second part of the fastening mechanism may comprise multiple eyes. Accordingly, by selecting different eyes a wearer may selectively increase or decrease a circumference of the bra.
  • the one or more forces acting on the breast tissue may comprise gravity.
  • the bra may comprise a plurality of inserts.
  • the or each insert may comprising a plurality of inflatable or inflated bodies.
  • the plurality of inflated or inflatable bodies may be interconnect by one or more channels or tubes.
  • the plurality of inflated or inflatable bodies may be configured to be the same or different pressures.
  • the plurality of inflated or inflatable bodies are configured to be the same pressure.
  • the bra may comprise a plurality of fasteners.
  • the bra may comprise a fastener for each inflatable or inflated body.
  • Each fastener may be configured to secure an inflatable or inflated body in a position such that in use the insert applies pressure to a breast of the wearer to counter one or more forces acting on the breast tissue.
  • the fastener may be configured to reversibly secure the insert in a position. Accordingly, when the insert is secured in the position and the wearer is wearing the bra, the insert applies pressure to a breast of the wearer. Accordingly, an insert could be removed from the bra. This would allow the insert to be modified before being reattached or an alternative insert to be attached in its place.
  • the bra comprises a plurality of fasteners
  • the insert may be secured in a plurality of positions. This would allow the bra to be customised for a specific wearer and/ or to be modified as the needs of a wearer change.
  • the fastener may be configured to fixedly secure the insert in a position such that in use the insert applies pressure to a breast of the wearer.
  • an insert could be could be an integral component of the bra.
  • the or each fastener may comprise a pocket configured to house one or more inflatable or inflated bodies.
  • the fastener may comprise a two-part fastener, wherein a first part is disposed on the inflatable or inflated body and the second part is disposed on the first section, second section, first band or second band.
  • the first and second parts of the fastener may be configured to reversibly engage with each other.
  • the or each fastener may comprise hook and loop fastenings.
  • the or each fastener may be disposed on or substantially adjacent to the first section or the second section. Accordingly, in embodiments where the first and second sections define first and second cups, the or each fastener may be in or substantially adjacent to the first cup or the second cup.
  • One or more fastener may be configured to secure the or each inflatable or inflated body substantially below the nipple of a wearer in use.
  • the or each fastener is configured to secure the or each inflatable or inflated body substantially below the nipple of a wearer in use.
  • the phrase below the nipple may be understood to refer to an area below the centre of the wearer’s nipple, or for a wearer where the nipple has been removed by surgery the place where the centre of the nipple would otherwise be, when the wearer is standing up.
  • the phrase below the nipple may be understood to encompass an area which is to the side of the nipple, and is below the centre thereof when the wearer is standing up.
  • the or each inflatable or inflated body may be understood to be substantially below the nipple of a wearer if at least 50%, at least 60%, at least 70%, at least 80%, at least 90% or 100% of the volume of the or each inflatable or inflated body is below the nipple of a wearer in use.
  • the bra may comprise one or more fasteners, configured to secure one or more inflatable or inflated bodies substantially adjacent to the inframammary fold of a breast of the wearer in use.
  • the bra may comprise one or more fasteners configured to secure one or more inflatable or inflated bodies substantially adjacent to the inframammary fold of the left breast of the wearer in use.
  • the bra may comprise one or more fasteners configured to secure one or more inflatable or inflated bodies substantially adjacent to the inframammary fold of the right breast of the wearer in use. Accordingly, the one or more fasteners and one or more inflatable or inflated bodies maybe disposed substantially adjacent to the first and/or second sections.
  • the one or more fasteners may secure the one or more inflatable or inflated bodies to the first and/or second sections.
  • the one or more inflatable or inflated bodies may be configured to provide an upward pressure on a wearer’s breast in use.
  • An upward pressure may be understood to be a pressure which is in an upward direction when a wearer is standing up.
  • this counters the force of gravity and provides support to the area of the inframammary fold.
  • the bra may comprise one or more fasteners, configured to secure one or more inflatable or inflated bodies substantially adjacent to an outer side of the breast of the wearer in use.
  • An outer side of a breast may be understood to be the side of the breast substantially adjacent to a wearer’s armpit. Accordingly, the left side of a wearer’s left breast will be understood to be the outer side of the wearer’s left breast and the right side of a wearer’s right breast will be understood to be the outer side of the wearer’s right breast.
  • the bra may comprise one or more fasteners configured to secure one or more inflatable or inflated bodies substantially adjacent to the left side of the left breast of the wearer in use.
  • the bra may comprise one or more fasteners configured to secure one or more inflatable or inflated bodies substantially adjacent to the right side of the right breast of the wearer.
  • the one or more fasteners and one or more inflatable or inflated bodies may be disposed substantially adjacent to the first and/or second sections and/or the first band.
  • the one or more fasteners may secure the one or more inflatable or inflated bodies to the first and/or second sections and/or the first band.
  • the one or more inflatable or inflated bodies may be configured to provide an inward pressure on a wearer’s breast in use. Inward pressure may be understood to be pressure which is in a direction towards the area between the wearer’s breasts. Advantageously, this counters lateral movement of the breast. This can be particularly beneficial for a wearer who has undergone a T- incision.
  • the bra may comprise one or more fasteners, configured to secure one or more inflatable or inflated bodies substantially adjacent to a central side of the breast of the wearer in use.
  • a central side of a breast may be understood to be the side of the breast substantially adjacent to a wearer’s middle.
  • the right side of a wearer’s left breast will be understood to be the central side of the wearer’s left breast
  • the left side of a wearer’s right breast will be understood to be the central side of the wearer’s right breast.
  • the bra may comprise one or more fasteners configured to secure one or more inflatable or inflated bodies substantially adjacent to the right side of the left breast of the wearer in use.
  • the bra may comprise one or more fasteners configured to secure one or more inflatable or inflated bodies substantially adjacent to the left side of the right breast of the wearer.
  • the one or more fasteners and one or more inflatable or inflated bodies may be disposed substantially adjacent to the first and/or second sections and/or the second band.
  • the one or more fasteners may secure the one or more inflatable or inflated bodies to the first and/or second sections and/or the second band.
  • the one or more inflatable or inflated bodies may be configured to provide an outward pressure on a wearer’s breast in use. Outward pressure may be understood to be pressure which is in a direction away the area between the wearer’s breasts.
  • this also counters lateral movement of the breast and can be particularly beneficial for a wearer who has undergone a T-incision.
  • the inserts may be configured to allow the pressure therein to be varied.
  • the inserts may comprise, or be configured to receive, a pressurized fluid.
  • the fluid may be a liquid, a gas or a gel.
  • the fluid is a gas.
  • the or each insert may comprise a port configured to allow inflation and/or deflation of the inflated or inflatable body.
  • each body may comprise a port to independently allow inflation and/or deflation thereof.
  • a single port may allow inflation and/or deflation of each body.
  • the port maybe disposed in or substantially adjacent to the inflated or inflatable body.
  • the or each insert may comprise a conduit adjacent to the port, wherein the conduit is configured to transport a fluid to and/or from the port.
  • a first end of the conduit may be disposed adjacent to the port.
  • the second end of the conduit maybe spaced apart from the inflated or inflatable body.
  • the fastener comprises a pocket
  • the second end of the conduit may be disposed outside of the pocket.
  • the bra may comprise a sleeve configured to house a second end of the conduit.
  • the conduit may comprise a flexible tube.
  • the port maybe disposed spaced apart from the inflated or inflatable body and a conduit may extend therebetween.
  • a first end of the conduit may be disposed adjacent to the inflated or inflatable body.
  • the second end of the conduit may be spaced apart from the inflated or inflatable body.
  • the fastener comprises a pocket
  • the second end of the conduit may be disposed outside of the pocket.
  • the port maybe disposed substantially adjacent the second end of the conduit.
  • the bra may comprise a sleeve configured to house a second end of the conduit.
  • the conduit may comprise a flexible tube.
  • the pressure within the or each insert can be adjusted without the need to remove the insert from the pocket.
  • the or each insert may comprise an inflation port configured to allow inflation of the inflated or inflatable body.
  • the or each inflated or inflatable body may comprise an inflation port configured to allow inflation thereof.
  • the or each inflation port may comprise an airtight seal.
  • the airtight seal may comprise a valve.
  • the valve may be a one-way valve.
  • the airtight seal may comprise a release mechanism. This would allow the body to be deflated. Alternatively, the airtight seal may not comprise a release mechanism.
  • the valve is made in accordance with, or reflects the teaching in US Patent No. 4917646.
  • the valve may comprise (i) a first flexible plastic valve sheet defining a first inlet end and a first outlet end, and (ii) a second flexible plastic valve sheet defining a second inlet end and a second outlet end, wherein the first and second flexible plastic valve sheets are secured together to define a valve inlet and a valve outlet.
  • the second inlet end of the second flexible plastic valve sheet may extend beyond the first inlet end of the first flexible plastic valve sheet to define a positioning tab that is secured within the flexible tube.
  • the valve may be positioned such that a fluid disposed with the body acts on an external surface of the first and second flexible plastic sheets. Accordingly, the pressure exerted by a fluid within the inflated or inflatable sheet may force the valve to close.
  • Each plastic valve sheet may be a low-density polyethylene (LDPE) sheet or similar suitable material.
  • the first and second flexible plastic valve sheets may be sealed together, for example by heat sealing, thereby forming the shape of the valve.
  • the valve outlet has a smaller width than the valve inlet.
  • the valve may further comprise (iii) a bonding barrier disposed between the first and second flexible plastic valve sheets substantially adjacent to the valve inlet.
  • the bonding barrier may comprise heat-resistant ink.
  • valve may reflect the teaching in US Patent No. 5188558.
  • This relates generally to a self-sealing, reusable plastic balloon valve made from two or more flexible plastic sheets bonded together to define a valve inlet, a valve outlet, and a fluid channel which is self-sealing upon inflation of the balloon and removal of the fluid source.
  • the self-sealing apparatus being adaptable for reuse and reopening for refilling or partial refilling of the plastic balloon.
  • the or each insert may comprise a deflation port configured to allow inflation of the inflated or inflatable body.
  • the deflation port may comprise a stopper, configured to reversibly seal the deflation port.
  • the or each inflated or inflatable body is inflated or configured to inflate to a positive pressure of at least 50 Pa, at least 100 Pa, at least 150 Pa, at least 200 Pa or at least 250 Pa.
  • the pressure can be varied for a given wearer to ensure it is suitable to the patho-physiological, or clinical features.
  • the insert(s) may be configured to apply pressure to between to and 100% of the area below the nipple on one or each breast.
  • the insert(s) are configured to apply pressure to between 20 and 90%, between 30 and 80%, between 35 and 70%, between 40 and 60%, between 45 and 55% of the area below the nipple on one or each breast.
  • the breast can be considered spherical in shape. Accordingly, the area of the breast below the nipple may be calculated using the following equation:
  • the half circumference of the breast (C/2) maybe measured by measuring the length of a horizontal line across the breast.
  • the horizontal line preferably passes through the centre of the nipple.
  • the half circumference of the breast may be measured when the wearer is in a standing position.
  • the half circumference of the breast of a wearer may be under to be the same as the half circumference of the cup of the bra.
  • the insert(s) maybe configured to apply pressure to an area of between too and 10,000 mm 2 on one or each breast.
  • the insert(s) are configured to apply pressure to an area of between 200 and 7,500 mm 2 , between 300 and 5,000 mm 2 or between 400 and 2,500 mm 2 on one or each breast. More preferably, the insert(s) are configured to apply pressure to an area of between 500 and 2,000 mm 2 , between 600 and 1,750 mm 2 , between 700 and 1,500 mm 2 or between 800 and 1,250 mm 2 on one or each breast.
  • the insert(s) are configured to apply pressure to an area of between 900 and 1000 mm 2 on one or each breast. It maybe appreciated that the area to which pressure is applied may vary depending upon the breast size of a wearer.
  • the or each inflated or inflatable body may define two or more ribs.
  • the ribs may be defined by stitching or moulding of the body.
  • the ribs help to increase the rigidity of the body and maintain the shape of the body upon inflation.
  • the bra may comprise an underbust band.
  • the underbust band may be provided adjacent to the first and second sections.
  • the underbust band maybe disposed adjacent to the first band.
  • the underbust band may be disposed adjacent to the second band.
  • the underbust portion may be disposed below the first and second sections, the first band and/ or the second band. It may be appreciated that the term below means that the underbust band is disposed below these sections when a wearer is wearing the bra and is in a standing position.
  • the underbust band may be configured to improve the fit of the bra. Accordingly, the underbust band may better secure the bra in position on a wearer.
  • a kit comprising the bra of the first aspect and one or more flex sensors.
  • the kit allows a user to measure the tension in a wearer’s skin and adjust the pressure in the inserts as required to reduce the tension.
  • the kit may further comprise a multimeter.
  • the kit may further comprise a pressure sensor.
  • the kit may further comprise a pump.
  • the kit may comprise a plurality of inserts. Accordingly, a user could select the preferred insert(s) for a specific wearer.
  • the kit may comprise a controller.
  • the controller may be configured to control the pump.
  • the controller maybe configured to receive readings from the one of more flex sensors.
  • the controller may be configured to control the pump, and thereby vary the pressure in the one or more inserts, to reduce the tension in a wearer’s skin.
  • a method of adjusting a bra for a wearer comprising: disposing the bra of the first aspect on a wearer; measuring tension in the skin on the wearer’s breast; and varying the pressure in the one or more bodies, the volume of the one or more bodies and/ or the location of the one or more bodies to determine an optimum pressure, volume and/or location.
  • the optimum pressure, volume and/or location maybe a pressure, volume and/or location at which tension in the skin is reduced compared to when the wearer is not wearing the bra.
  • the optimum pressure, volume and/ or location may be viewed as the pressure, volume and/or location at which tension in the skin of the wearer’s breast is lowest.
  • the lowest achievable tension may not be optimal.
  • the lowest tension may only be achievable when the wearer experiences discomfort or another adverse outcome.
  • the optimum pressure, volume and/or location may be the lowest pressure, volume and/or location at which the wearer does not experiences discomfort and/or another adverse outcome.
  • Varying the pressure and/or the volume of the one or more bodies may comprise pumping air into or releasing air from an insert.
  • varying the pressure and/or the volume of the one or more bodies may comprise removing positing one or more inserts from the bra and securing one or more alternative inserts to the bra using the fastener.
  • the method comprises varying the pressure in the one or more bodies to determine an optimum pressure.
  • the tension in the skin may be measured substantially adjacent to an area of interest.
  • An area of interest may be a surgical incision.
  • tension in the skin maybe measured substantially adjacent to the inframammary fold, between the inframammary fold and the nipple, at an outer side of the breast and/or at a central side of the breast.
  • the tension in the skin is measured substantially adjacent to the inframammary fold, between the inframammary fold and the nipple, at an outer side of the breast below the nipple and/ or at a central side of the breast below the nipple.
  • the tension in the skin is measured substantially adjacent to the inframammary fold. This may be particularly beneficial if the wearer has undergone a T-incision.
  • Figure la-ie show common incisions associated with breast surgery: a: Inframammary Fold Incision (used for nipple sparing mastectomy); b: Lateral Mammoplasty Incision; c: Eliptical Incision for Skin Sparing Mastectomy; d: Lateral Incision (used for skin sparing/areola sparing mastectomy); e: Wise pattern (inverted T) incision (used for therapeutic mammoplasty or skin reducing mastectomy and reconstruction).
  • Figure 2a T-incision with arrows showing wound forces in unsupported breast
  • Figure 2b T-incision with arrows showing forces which it is desirable to have acting on the breast and wound;
  • Figure 3 Graph showing relationship between resistance of flex sensors and inserts pressure for various breast volumes
  • FIG. 1 Model showing 6 strain reading points
  • Figure 6 Graph showing relationship between skin strain and insert pressure
  • Figure 7a Modelled strain map showing inframammary fold strain with and without application of lsooPa
  • Figure 7b Modelled strain map side view of breast displacement upon application of i500Pa
  • Figure 8a Graph showing skin strain and insert pressure at points C, D and E;
  • Figure 8b Modelled strain map showing effect of pressure above critical point where the application of increased pressure causes strain to increase
  • Figures 9a-9e Show various locations for inserts in a bra in accordance with a first aspect
  • Figures loa-ioc Diagrams of bras in accordance with a first aspect
  • Figure tod Diagram of inserts for use in a bra according to a first aspect.
  • the breast is a complex structure made up of various tissues, several of which are anisotropic.
  • Gefen and Dilmoney (Technol Health Care. 2007; i5(4):259-7i) determined the mechanical properties of tissue components of the breast in young healthy individuals and from this, demonstrated the internal force acting on the breast in the young healthy individuals whilst standing, lying flat, whilst in motion and kneeling on all fours.
  • the tension forces in the Cooper’s ligaments help to counteract the weight of the breast and stops the tissue from sagging.
  • the support provided by these ligaments is limited.
  • the breast tissues and overlying skin are subject to tension resulting in skin strain.
  • Kraissl's lines are a set of anatomical lines which define the lines of maximum skin tension.
  • the present inventors have devised a bra comprising a novel means for providing adjustable support to the breast, especially in a sporting or post-surgical situation.
  • the bra provides support to the site of a surgical wound in order to improve comfort, reduce pain, and provide optimal and adaptable breast support in the post operative period.
  • the bra also has a wider application, for example for use in sport.
  • Figures loa-ioc provide examples of bras according to the first aspect.
  • the basic shape of a bra according to the first aspect conforms or largely conforms to the shape of known standard or sports bras.
  • the bra (1) comprises first and second cups (2) for location over the breasts; a first band (3b), for location around the torso in use.
  • the first band (3b) extends from an outer side of the first cup (2) to an outer side of the second cup (2).
  • the bra (1) further comprises a second band (3a), for location between the breasts in use.
  • the second band (3a) extends from an inner side of the first cup (2) to an inner side of the second cup (2).
  • the second band (3a) comprises a first panel, a second panel and a fastening mechanism (4) configured to reversibly connect the first and second panels together. Accordingly, the fastening mechanism (4) is disposed on the front of the bra, between or substantially between the bra cups.
  • the first band (3a) may comprise first and second panels and a fastening mechanism (4) configured to reversibly connect them.
  • the fastening mechanism (4) may be disposed at the back or side of the bra. In some embodiments, it may be disposed to be located substantially in the midpoint of the wearer’s back in use.
  • the bra may further comprise an under-bust band (5), configured to be disposed under the bust in use.
  • the under-bust band (5) shown in Figures toa-d extends from a first side of the first panel to a first side of the second panel. This maybe of one or two or more layers and may house a mechanism/tube or channel.
  • the bra further comprises at least one inserts (9), the or each insert comprising a body which is either inflated or configured to be inflated.
  • the inserts are used to apply - l6 - localised pressure to a desired area of the breast and/ or to achieve volume displacement of the breast.
  • the bra comprises one or more fasteners configured to fasten the one or more inserts to an internal surface of one or both of the cups.
  • the or each fastener comprises a first portion disposed on an internal surface of one or both cups and a second portion disposed on the or each insert.
  • the fastener comprises a hook and loop fastening (e.g. VelcroTM).
  • the bra comprises one or more pockets (12), the or each pocket being configured to house at least a portion of the insert.
  • the or each pocket is configured to house the body of the insert.
  • the or each pocket may be configured to house a portion of at least one insert.
  • the or each pocket is configured to house a portion of one insert.
  • the or each pocket (12) maybe located in one of the cups, the first band and/or the second band.
  • a pocket (12) may be located thereon.
  • a first pocket is disposed in the left cup and a second pocket is disposed in the right cup.
  • the or each pocket is disposed on an inner surface of the or each cup. The inner surface may be understood to be located adjacent to the skin of a wearer.
  • the pocket maybe made of any suitable material.
  • the material is elasticated or partially elasticated.
  • the shape and/or location of the pockets substantially corresponds to the shape of the body to be located therein.
  • an open end of the pocket is dimensioned and/or shaped to allow easy insertion of the insert into the pocket.
  • an open end of a pocket has a width of between 10 mm and too mm, between 20 mm and 80 mm, between 30 mm and 70mm, between 40 mm and 60 mm or between 45mm and 55 mm.
  • the or each insert (9) maybe made of any suitable material.
  • the or each insert may comprise a polymer.
  • the polymer may be a thermoplastic polymer and/or an elastomer.
  • the insert may comprise rubber and/or polyurethane (PU) coated nylon.
  • the inserts may have thermal properties, in that they may be made of a thermal material and/or comprise a mechanism which, upon activation, initiates an exothermic reaction. The application of heat can be advantageous as it can aid wound healing.
  • the or each insert (9) comprise one or more ‘ribs’ (9a), as shown in Figure tod.
  • ribs may be defined by stitching, moulding, channels or different thickness of material. Such ribs help to increase the rigidity of the insert and maintain the shape of the insert upon inflation.
  • the inserts may be inflated using a fluid or a gel.
  • the inserts maybe inflated by location of a flocking material such as a Fibrefill; or a granular material such as beads or pellets inside the insert.
  • the beads or pellets maybe made of any suitable material, with examples including PP Beads and EPS Beads.
  • the inserts may be inflated using gas or a gel.
  • the gas may be air or nitrogen.
  • the inserts may be of shape suitable to a specific type of surgical incision or intervention or specific situation. Accordingly, the inserts may define a crescent, circular, doughnut, cylindrical, semi cylindrical and/or polygonal shape.
  • the insert may be of suitable material, size, feel and shape to fill the volume void after breast surgery.
  • the or each insert comprises one or more ports (10), via which inflation and/or deflation of the insert maybe achieved.
  • the or each port may provide a connection between an interior and exterior of the insert.
  • the or each port may comprises an airtight and/or leak proof seal (10a), such as a valve.
  • the or each port may further comprise a flexible tube (10b).
  • the flexible tube may extend between the body and the seal.
  • the seal may be disposed adjacent to the body.
  • the seal may be disposed between the body and the flexible tube.
  • the valve of the port is self-sealing.
  • each insert comprises a single port which allows inflation and deflation.
  • each insert comprises an inflation port, configured to allow inflation of the body, and a deflation port configured to allow deflation of the body.
  • the inflation port may comprise a non-return valve. - l8 -
  • the ports are designed such that, once the desired level of inflation has been achieved, the port can be manipulated so as to avoid or minimize protrusion of the port from the surface of the body. For example, by having the seal substantially flush with the surface of the body. This can be beneficial for comfort reasons, and can reduce the possibility of irritation to the skin as a result of any significant protrusion from the surface of the insert.
  • the bra may comprise one or more sleeves (11) in which at least a portion of the one or more port(s) maybe located.
  • a first sleeve is provided to house at least a portion of the inflation port
  • a second sleeve is provided to house at least a portion of the deflation port.
  • the or each sleeve and/ or the or each port may be configured so as to allow location of at least a portion of the flexible tube, and optionally also the seal, in the sleeve.
  • the sleeve may define a diameter suitable to host the tube e.g. 25 mm.
  • the or each sleeve may be located at the front, side, top, bottom or any suitable site of the bra.
  • the or each sleeve may be located substantially parallel or at an angle to the fastening means.
  • the bra maybe provided with two sleeves (11a and 11b) disposed either side of, and substantially parallel to, a two-part complementary closure which forms the fastening mechanism.
  • Such an arrangement (which is shown in Figure 10b) could accommodate the tube or channel of the port.
  • the sleeves may be made of any suitable material.
  • the material is elasticated or partially elasticated.
  • the pocket may define one or more openings configured to allow the tube to extend from the pocket and optionally into a sleeve. This arrangement allows inflation and/or deflation ports to extend from the pocket, for example for location in, or via location in a sleeve, and can allow the inflation or deflation ports to extend to the outside of the bra.
  • the insert comprises two or more bodies, wherein each body is either inflated or configured to be inflated.
  • the two or more bodies may be connected by a tube.
  • the insert may comprise a single port, to allow inflation and/or deflation of the two or more bodies.
  • the two or more bodies may define different shapes and/or stiffnesses, to allow different inflation profiles.
  • Such an arrangement can be beneficial as the single port and/ or the tubing of the port can be located in a sleeve on the bra; thus allowing easy access for inflation or deflation of all bodies via a single port.
  • the insert(s) may be provided with a covering, for example a covering of material. This can increase comfort and aid location of the insert in the bra.
  • the covering comprises or consists of antimicrobial and/ or anti inflammatory material.
  • the cups at least partially cover the breast in use.
  • the cups may be demi-cups, in that they cover only part of the breast in use.
  • the cups may be full cups in that they fully cover or substantially cover the breast in use.
  • the cup should be suitable to encase the prosthetic, to ensure that it is held in place and does not fall out.
  • the cups are composed of two parts, linked together by a fastening means so that the upper part of the cup is detachable from the lower part of the cup.
  • the fastening means may comprise a two-part complementary closure with one part located on each side of the cup parts to be secured together.
  • the closure may be, for example, comprise a hook and eye fastener, a zip, hook and loop fastenings (e.g. VelcroTM), or attracting magnets.
  • the material(s) used to create the component parts of the bra may conform to any of those used in known bras, or may be any suitable material.
  • the material used to create the cups, the first band, the second band and/or the under bust band is a material which is known to have a high perceived comfort factor by wearers.
  • the material is soft, breathable and/or made from natural materials. These factors can prevent skin irritation, help to dissipate heat which can be important for wound healing, and/or improve the comfort for the wearer.
  • the component parts of the bra may comprise a fabric such as cotton, acrylic or silk or an elasticated material such as powernet (also known as TechsheenTM), nylon, elastane, spandex, or a combination thereof.
  • at least part of the first band, the second band, under-bust band and/or cups is made from a fabric which comprises an elasticated material.
  • all or substantially all of the first band, the second band, under-bust band and/or cups is made from a fabric which comprises an elasticated material.
  • Use of an elasticated material can be beneficial as it provides a generalised compressive force to the wearer when the bra is in use.
  • the cups, the first band, the second band and/ or the under bust band are seam-free, as this improves the comfort for the wearer and reduces skin irritation.
  • the cups, the first band, the second band and/or the under bust band or a part thereof comprise fabric which is transparent or translucent.
  • the transparent or translucent material is localised to one or more of the areas which have undergone surgery such as one or more of the incised areas of the breast.
  • one or both of the cups are provided with a ‘window’ to allow the underlying area of breast tissue to be examined without removal of the bra. This may be achieved by, for example, using transparent material(s) for the relevant areas of the cup(s).
  • the window is localised to one or more of the areas which have undergone surgery, for example, the window may be localised to one or more of the incised areas of the breast.
  • the cups, the first band, the second band and/or the under bust band may comprise a single layer of material.
  • the cups, the first band, the second band and/or the under bust band may comprise more than one layer of material, which maybe the same material, or two or more different materials.
  • the cups may comprise a double layer of material, which may be the same material or two different materials, giving rise to an inner surface of the cup which is next to or closest to the skin of the wearer, and an outer surface of the cup, which is furthest from the skin of the wearer.
  • one or more of the layers may be an absorbent material in order, for example, to help keep the wound clean and dry.
  • the absorbent material may be an inner layer of material.
  • the cups comprise one or more layers of padding between inner and outer layers of material.
  • padding can be beneficial for comfort and aesthetic reasons, as it can help to provide the cups with a desirable shape, hide the nipple or its absence thereof, and address asymmetrical breast sizes. Such factors can be important to the wearer, as they help provide an agreeable outline under the wearer’s clothes. It may be appreciated that an inner layer of material would be disposed adjacent to a wearer’s skin in use. Similarly, an outer layer of material maybe disposed opposite to the inner layer, and may to contact a wearer’s skin in use.
  • the bra, cups, the first band, the second band and/or the under bust band may comprise an outer (i.e. furthermost from the skin of the wearer) layer, which may be for aesthetic purposes, for example, to hide the underlying features of the bra, or to add a colour, texture, feel or other aesthetic quality to the bra.
  • under band or layer may have special features such as made of absorbent material and disposable/changeable.
  • the bra, the cups, the first band, the second band and/or the under bust band may comprise an inner layer of material.
  • the bra comprises material which has antimicrobial properties. All or some of the material located next to or closest to the skin of the wearer may have antimicrobial properties. For example, it maybe coated or impregnated with an antimicrobial substance. In some embodiments, all or some of an inner surface of at least one of the cups has antimicrobial properties. It maybe appreciated that the inner surface of the cup would be disposed adjacent to a wearer’s breast in use.
  • one or more of the materials used to create the bra may be a thermal material.
  • a thermal material can be beneficial as it can help to raise, maintain or optimise skin temperature, which can aid healing.
  • the thermal material could comprise nylon and/ or acrylic.
  • one or more of the layers of material used to create the bra may be an electrically conductive material.
  • the use of electric conductive fabric/material can be beneficial as it can monitor or help to monitor or manage electrocardiographic or other heart or bodily functions during daily life, or, for example over a particular period of time such as during a sports activity or in the post-surgical period.
  • an inner layer of the bra may comprise an electrically conductive material.
  • one or more of the cups, or one or more parts of the cups have an increased stiffness or ribs of stressed material in comparison to the first band, the second band, the under-bust band and/or other aspects of the bra.
  • one or more parts of the cups may comprise a material having increased stiffness. In some embodiments, this is achieved by insertion of an additional layer of material having increased stiffness between the two layers of material from which the cup is composed.
  • a material with increased stiffness may be used to create the structure of the cup, which is then covered on one or both sides with a less stiff, fabric like material.
  • the incorporation of a material with increased stiffness into the cup can be beneficial to provide protection, give shape or to reduce movement of the breast. It may be appreciated that a material having increased stiffness may be a material with increased stiffness relative to the material which forms the first band, the second band and/ or the under-bust band.
  • the material with increased stiffness may nevertheless be somewhat flexible.
  • Suitable materials for use to impart stiffness to the cup include plastics, rigid or semi-rigid nylon, or other polymer-based materials.
  • the fastening mechanism (4) may comprise a two-part complementary fastener comprising a first closure component disposed on the first panel and a second closure component disposed on the second panel.
  • the first and second closure components may be configured to reversibly fasten together.
  • the first closure component is disposed substantially adjacent to a first side of the first panel and the second closure component is disposed substantially adjacent to a first side of the second panel.
  • the fastening mechanism may comprise a hook and eye fastener, a zip, hook and loop fastenings (e.g. VelcroTM), string or attracting magnets.
  • the fastening mechanism is adjustable.
  • the fastening mechanism may be viewed as being adjustable if it allows the size of the band to be adjusted.
  • the first closure component may comprise several eyes or rows of eyes and the second closure component may comprise a hook. Accordingly, location of the hook on a selected eye or row of eyes can adjust the size of the band and provide the required tension on the bra around the torso.
  • the first closure component may be disposed on an outer surface of the first panel.
  • the second closure component maybe disposed on an outer surface of the second panel. Accordingly, this ensures that the fastening mechanism does not directly contact the wearer’s skin.
  • the bra may comprise a second two-part complementary fastener comprising third and fourth closure components configured to reversibly fasten together.
  • a first two-part complementary fastener may comprise a first closure component disposed on the first panel and a second closure component disposed on the second panel.
  • the first two-part complementary fastener is a zip.
  • the first closure component may comprise a first zip element comprising zip teeth and the second closure component may comprise a corresponding second zip element comprising zip teeth.
  • One of the first and second enclosure components may comprise a zip slider.
  • the bra may comprise a third panel, configured to reversibly extend over the first two- part complementary fastener.
  • the third closure component may be disposed on the third panel.
  • the third closure component is disposed substantially adjacent to a first side of the third panel.
  • the third panel may be attached to the first panel, preferably on an outer surface thereof.
  • a second side of the third panel is attached to the first panel.
  • the second side of the third panel is attached to the first panel at a position spaced apart from the first side of the first panel.
  • the second side of the third panel is preferably opposite the first side thereof.
  • the fourth closure component is disposed on the second panel, and preferably on an outer surface thereof.
  • the fourth closure component is disposed on the second panel at a position spaced apart from the first side of the second panel. Accordingly, when the third and fourth closure components are fastened together the third panel will extend over the first two-part complementary fastener.
  • the fourth closure component is disposed on a fourth panel.
  • the fourth closure component is disposed substantially adjacent to a first side of the fourth panel.
  • the fourth panel may be attached to the second panel, preferably on an outer surface thereof.
  • a second side of the fourth panel is attached to the second panel.
  • the second side of the fourth panel is attached to the second panel at a position spaced apart from the first side of the second panel.
  • the second side of the fourth panel is preferably opposite the first side thereof. Accordingly, when the third and fourth closure components are fastened together the third and fourth panels define a band which extends over the first two-part complementary fastener.
  • the third and/or fourth panels may comprise the same material as defined above in relation to the cups, the first band, the second bands and/ or the under-bust band.
  • the bra does not comprise any shoulder straps, as shown in Figure 10c.
  • the bra further comprises one or two shoulder straps (6), and preferably comprises two shoulder straps, as shown in Figures 10a and 10b.
  • a shoulder strap may be a width of material that extends over the shoulder of the wearer between the first panel (3b) and a cup (2).
  • the straps may vary in width over their length, for example, the strap may be broad at the point it is joined to the cup and / or the first band, and then taper as it extends over the area of the shoulder.
  • the shoulder straps form an integral part (i.e. non-removable) of the bra.
  • the shape of the shoulder straps at the points at which they are secured to the bra complements the surface to which they are secured.
  • the strap may be curved to coordinate with the curve of the cup at that point.
  • the shoulder straps are removable from the bra.
  • the cups and/ or band of the bra and the shoulder straps comprise complementary fasteners, to allow the shoulder straps to be reversibly attached to the bra.
  • each shoulder strap comprises a single width of material.
  • one or both of the shoulder straps comprise two widths of material.
  • the widths of material are secured to different locations on the cups.
  • the widths of material may be secured to the band and the back of the bra at different locations.
  • one or more of the shoulder straps comprises a single width of material where secured to the cups and back band of the bra, which split into two at a distance from the securing points.
  • the or each shoulder strap comprises at least one adjustment feature for altering the length of shoulder strap. Provision of adjustment features allows the length of shoulder straps to be altered thereby adjusting the amount of lift and support provided to the breasts.
  • the adjustment feature may comprise a slide mechanism, hook and loop fastenings (e.g. VelcroTM), or hook and eye fastenings.
  • the or each shoulder strap comprises an adjustment feature (7).
  • the bra (1) comprising a first shoulder strap (6), comprising a first portion (6a), which is attached to a first cup (2), and a second portion (6b) which is attached to the first panel (3b).
  • the bra (1) preferably comprises a second shoulder strap (6), comprising a first portion (6a), which is attached to a second cup (2), and a second portion (6b) which is attached to the first panel (3b).
  • the adjustment feature (7) may comprise a fastener configured to reversibly connect the first and second portions (6a and 6b).
  • the shoulder strap is preferably configured such that the fastener (7) is disposed towards the front of the bra in use.
  • the fastener may comprise a hook and eye fastener, a zip or hook and loop fastenings (e.g. VelcroTM).
  • the fastener (7) comprises a hook and eye fastener.
  • the hook and eye fastener may comprise a hook and a plurality of corresponding eyes or an eye and a plurality of corresponding hooks.
  • the padding is configured to prevent the fastener from contacting a wearer’s skin.
  • each shoulder strap comprises two widths of material secured to the cup and/ or band of the bra at different locations.
  • a shoulder strap may comprise a first width of material extending between the first band and a first position on a cup and a second width of material extending between the first band and a second position on the cup, such that the first and second positions are spaced apart.
  • the first position may be substantially adjacent to the outer side of the cup and the second position maybe substantially adjacent to the inner side of the cup.
  • Each width of material may comprise an adjustment feature. This arrangement allows the left-hand side and the right-hand side of the cup to be adjusted independently. This can be beneficial where additional support is needed on one side of the breast, for example, to provide support in an area of the breast which has undergone surgery.
  • the size, shape and/or location of the inserts are such as to apply pressure and/ or volume shift to the desired area(s) of the breast.
  • the inserts are sized, shaped and/or located in order to apply pressure to counter one or more forces acting on the breast tissue.
  • the one or more forces acting on the breast tissue are as a result of a surgical incision.
  • the one or more of the forces acting on the breast tissue are as a result of sporting activity.
  • the inflation pressure or volume of the insert(s) is such as to apply a desired level of pressure or positional support to the breast. In preferred embodiments, the inflation pressure of the insert(s) is such as to counter one or more forces acting on the breast tissue. In some embodiments, the one or more forces acting on the breast tissue are as a result of a surgical incision. In alternative embodiments, the one or more of the forces acting on the breast tissue are as a result of weight of the breast. In alternative embodiments, the one or more of the forces acting on the breast tissue are as a result of sporting activity.
  • the forces resulting from sporting activity can result, for example, from general body motion such as walking and/or general sporting movement; or a particular type of sport (for example running in a substantially linear direction generates different forces on the breast to participation in a sport requiring torso rotation at speed, such as squash).
  • the forces on the breast tissue may result from surgery or any other intervention.
  • a surgical incision cuts the breast tissues into two sides ( Figures 1 and 2a), for example above the incision and below the incision when the incision is horizontal; or left of the incision and right of the incision when incision is vertical.
  • the weight of the breast can place strain on the incision line resulting in wound opening, for example, for procedures involving incisions below the nipple, such as the mastopexy T incision, the weight of the breast can cause the wound to open (Figure 2a). Also, the weight of the breast can place strain on the site of intervention or on surrounding area. It is desirable for pressure to be applied to counter these forces (Figure 2b).
  • the size, shape and/or location of the inserts is such as to allow application of pressure or repositioning to or substantially to or adjacent to a surgical incision line.
  • the size, shape and/or location of inserts is tailored to subjects who have undergone breast surgery involving incision, such as a T- incision.
  • the size, shape and/ or location of inserts is tailored to subjects who have undergone breast surgery involving one or more of a J, L or mammary fold or other incision.
  • the size, shape and/or location of the inserts is such as to allow application of pressure to an area prone to certain disease process such as lymphoedema, or bleeding from a wound.
  • inserts will be placed on the upper, lateral or lower side, or any of these combinations of the breast so as to prevent the breast implants from dislocation.
  • Figures 9a-9e show various designs for a bra according to the first aspect.
  • the bra conforms to a standard sports bra shape with inserts located therein.
  • Figure 9a shows a bra with inserts forming a similar shape to that of an underwire.
  • This arrangement provides support to the inframammary fold.
  • FIGs 9c and 9d additional inserts have been added towards the armpit. These inserts aid compression of the sides of the breast to prevent the incised/reconstructed breast from lateral movement towards the armpit. Additionally, in Figure 9d, the insert located towards the front midline of the bra helps to stabilize the breast tissue and position it centrally or in a natural neutral position. This design can be beneficial for operations involving a T incision as due to the weight of the breast, the wound is forced open, and the skin pulled horizontally along the lines of maximum tension as shown in Figure 2a.
  • Figures 9e shows the location of three sets of inserts, separated by a gap, loosely duplicating the underwire shape. Provision of three separate inserts allows different pressures to be applied in different areas of the breast tissue. The inserts apply pressure to lift the breast, thereby providing support, which helps reduce wound tension. The inserts located to the side of the breasts help to stabilize the breasts and reduce tension, for example, resulting from the direction of the collagen in the skin.
  • the inflation pressure of the insert(s) is such as to counter one or more forces acting on the breast tissue as a result of a surgical incision.
  • the inflation pressure of the inserts may be such as to allow application of a desired pressure to a wound or surgical incision line.
  • the inflation pressure may be varied according to individual specifications, such as the weight and size of the breast and/or the extent, type and site of the incisions. For example, where the wearer has undergone breast surgery involving a T-incision, the inflation pressure of the insert(s) is such as to apply a pressure, in a particular wearer, for example, of around 600- 650 Pa to the breast. Also, this pressure may vary in the same wearer over a period of time depending upon the clinical picture.
  • the nature of an insert varies according to the desired inflation profile for that insert.
  • the weight of insert(s) can be tailored by a selection of appropriate inflation means, such as inflation using solid beads to counterbalance the loss of weight after breast reduction due to surgery following a mastectomy.
  • the size and/ or shape of the insert and/ or the stiffness of the material used to make the insert can be varied in accordance with the pressure or volume displacement that it is desirable to apply via that insert.
  • the size, shape and/or location of the insert(s) and/or the level of inflation of the insert(s) can be tailored to the wearer.
  • the volume, dimensions, composition and/ or tissue properties of the breasts vary between individuals; and in the same individual over a period of time, as a result of surgery, lifestyle, health, exercise regime and occurrence of childbirth and breastfeeding.
  • the weight of the normal breast can also vary between individuals, from less than 500g to around tooog, or more.
  • the needs of a wearer can change over time, for example, the condition of the breast tissue varies as a result of ageing, or healing post-surgery.
  • one or more of the size, shape, location and inflation pressure of the insert(s) is tailored to the needs of the wearer.
  • the needs of the wearer can be established using qualitative and/ or quantitative information.
  • measurements can be taken from the intended wearer of the bra, such as the weight or volume of the breast(s); and skin tension at one or more locations on the breast, such as along Kraissl’s line of maximum skin tension.
  • information can be pre-determined, for example using studies to establish typical forces acting at certain locations on the breast as a result of a particular surgical procedure or sporting movement.
  • Finite Element Analysis FEA can be used to establish the optimal size, shape, location and/or inflation pressure of inserts with respect to different surgical incisions.
  • Such information can be used to create a profile of the wearer, in order to establish the amount and location of pressure or volume displacement and other features/preferences required to counter the force(s) placed upon the breast tissue.
  • the requirements of the wearer may change over time, for example, due to reduction in swelling of the breast post-surgery.
  • An assessment of the wearer can therefore be carried out prior to and/or during use of the bra, for example, pre-surgery or pre sporting activity; and post-surgery and during recovery, or in lactating breasts post child birth to establish any changing need of the wearer with the regard to the amount of strain placed on the breast tissue, and the size, shape, location and/or inflation pressure of the insert in order to counter this strain.
  • the inserts are inflated to a pre-determined pressure(s), which maybe selected in order to apply a particular pressure to the breast at the location at which it is used.
  • the inserts are of various shapes and sizes e.g. semicircular, lacunar, linear, doughnut, discoid, circular etc. with varying surfaces such as concave convex surfaces and so on, as per the requirement of applying pressure or volume support.
  • the pressure within the insert(s) maybe adjusted.
  • Reasons for adjustment include to improve comfort to the wearer of the bra, change over time, to reduce skin tension or strain, to minimize discomfort or pain during activity or following breast surgery, and/or to tailor the pressure applied via the bra as the requirements of the wearer change, for example, as a result of the reduction in swelling post-surgery. Such adjustment can help to ensure that the application of pressure and/or fit of the bra is optimized and/or tailored to the wearer’s needs and/or to provide optimized conditions for healing in surgical situations or to minimize movement of the breasts during activity.
  • the pressure within the insert(s) may be adjusted by the wearer, carer, clinician or healthcare provider.
  • the wearer of the bra maybe provided with information regarding pressure settings for the insert(s).
  • pressure settings may include information regarding safe operating ranges, and one or more desired pressures or pressure ranges for the insert(s).
  • a wearer having undergone a particular surgical procedure may be provided with a set(s) of pressures to which the insert(s) can safely be inflated.
  • a set of pressures or pressure ranges maybe provided to the wearer as applicable for use in different physical activities (e.g. normal non-strenuous activities, strenuous activities such as running, and a setting for a sleeping) or with physiological changes such as in lactating breasts.
  • the pressure settings may be provided to the wearer by the carer, clinician or healthcare provider. The wearer may then adjust the inflation pressure in the inserts in accordance with the settings provided.
  • the pressure within the insert(s) maybe adjusted as a result of feedback.
  • Such feedback may be qualitative, for example verbal or written feedback from the wearer regarding for example, pain or discomfort, or following examination by a clinician, carer or healthcare provider.
  • such feedback may be quantitative, for example, as a result of one or more feedback mechanisms.
  • the feedback mechanism(s) provide information regarding the tension that the breast tissue is under. Examples of such feedback mechanisms include strain gauges or pressure sensors.
  • the feedback mechanism may be attached to the skin prior to securing the bra.
  • the bra or a component of the bra may comprise one or more such feedback mechanisms.
  • the bra, or a component(s) of the bra, such as the inserts maybe provided with sensors which provide information about the displacement of pre-determined reference point(s) on the skin.
  • the bra, or components of the bra, such as the inserts may be provided with one or more strain gauges. Such strain gauges maybe located next to the skin upon securing the bra in situ.
  • Such “wearable sensors”, which can be integrated into textiles or attached directly to the body, are known.
  • the information provided by the feedback mechanism(s) maybe provided to the wearer, carer, clinician or healthcare worker in any suitable format.
  • the feedback mechanism(s) is capable of remote monitoring.
  • the feedback mechanism may transmit information to a processing node using a suitable communication protocol, ideally a short-range and low-power wireless medium such as Bluetooth, ANT or ZigBee.
  • the processing mode could be a microcontroller, or a device such as a smartphone or computer.
  • the information provided by the feedback mechanism may be used to inform the decision as to the level of inflation of the inserts. In some embodiments such a mechanism maybe applicable to monitoring e.g. heart activity.
  • the pressure within the insert(s) is determined by an algorithm, which provides a pre-set safe operating range, and/or one or more pressures or pressure ranges for the insert(s). These pressures or pressure ranges may be tailored to the wearer, for example, the algorithm may provide a set(s) of insert inflation pressures for a wearer having undergone a particular surgical procedure; or a set(s) of pressures or pressure ranges for use in different physical activities (for example normal non- strenuous activities, strenuous activities such as running, and a setting for a sleeping).
  • the algorithm may be run on the processing node, which may store and display the results, for example to the wearer of the bra via an app, and/or transmit the measured data, for example over the internet to the carer, clinician or healthcare worker.
  • the pressure within one or more of the inserts is adjusted via a pump.
  • the port and/or tube of the port of the insert is sized so that the pump can be used to inflate or deflate the insert(s) via the port without removal of the insert from the bra.
  • the bra comprises one or more sleeves on the front of the bra, and the port and/or tube of the port is located in the one or more sleeves, to allow easy connection of a pump to the port for inflation and/ or deflation of the insert(s) without removal of the insert(s) from the bra.
  • the bra comprises one or more feedback mechanisms, preferably one or more wearable sensors, and the wearer receives information from the processing node about the level of inflation to a device such as a mobile phone or computer.
  • the wearer may also, optionally, receive an indication or alert when the level of inflation deviates from pre-set desired inflation levels.
  • the wearer can then attach the pump to the port of the relevant insert(s) and inflate or deflate the inserts(s) to the desired inflation level, as monitored by the sensors in communication with the processing node and reported to the wearer via the device.
  • a system comprising a post-surgical or sports bra which has a feedback mechanism to provide information regarding the tension the breast tissue is under according to the first aspect, and a processing node to which the feedback mechanism transmits information; and a means of inflating and/ or deflating the insert(s).
  • the feedback mechanism is capable of remote monitoring and the processing node is a smartphone or computer.
  • the means of inflating and/or deflating the inserts is a pump.
  • the inflation pressure of the insert(s) is set by one or more algorithms, wherein the algorithm(s) are run on the processing node.
  • an alert is provided by the processing node when the inflation pressure of the insert(s) deviates from the inserts inflation pressure setting(s) by a pre-determined amount, to alert the wearer to inflate or deflate the inserts accordingly.
  • a bra which applies pressure to the breast via one or more inflatable inserts to counter one or more forces acting on the breast, wherein the location and amount of pressure or volume displacement applied is tailored to one or more of: the physical requirements of the wearer (for example the wearer’s breast shape and/or cup size), the activity to be undertaken by the wearer (such as a particular sport), and the surgical procedure which the wearer is to undergo.
  • a bra allows pressure to be applied, via the insert(s), to selected areas of the breast which are known to need support in the activity or following the surgical procedure.
  • Such a bra is provided with pocket(s) and/or attachment means for location of the inserts in the desired areas.
  • Such a bra may be provided with the inserts in situ (either inflated, or for inflation by the clinician, health professional, carer or wearer).
  • the inserts maybe provided separately (inflated or uninflated).
  • the size, shape, location and / or inflation pressure of the inserts may be altered, for example in accordance with the needs of the wearer.
  • This tailored approach optimizes the amount and location of pressure and volume displacement applied to the breast. This can improve stabilization of the breast(s), reduce discomfort, aid healing and reduce bleeding, and lymphoedema etc post breast surgery, and other situations such as lactating breasts.
  • the bra is a single use item. In some embodiments the bra is disposable. In some embodiments the bra is a multiple use item.
  • the bra is comfortable to wear, including being comfortable when worn for prolonged periods of time.
  • the bra can provide an agreeable shape and/or outline under the wearer’s clothes, which can enhance the self-esteem of the wearer.
  • the support from the bra for the left and right breast acting against gravity needs to balance 5.67N and 5.79N, respectively.
  • the bra in this example comprised one insert per breast. When the inserts are inflated and sealed the internal pressure will be uniform against the walls. Below the nipple, the breast can be considered spherical in shape, although it is noted that this is an approximation. So if an insert covers half of the lower half of breast then the maximum contact area between the inserts and the breasts can be assumed to be an eighth of a sphere’s surface area.
  • the pressure needed in the inserts can be calculated using the following equation:
  • Step 1 Each subject’s breast volume was measured using the method discussed in Example 1, and the bra size worn by the subject was noted.
  • Step 2 Commercially available flex sensors were purchased. Two sensors were attached to each of the subject’s breasts using double sided tape along Kraissl’s lines of maximum skin tension. Consistency of location was ensured by measuring against the nipple and inframammary fold and adjustment till the sensors were symmetrical.
  • a multimeter was used to take readings of the sensor’s resistance in various positions. This was done whilst the subject was not wearing any garment in order to obtain a reading for the skin under natural tension. The subject had readings taken from all four sensors whilst in a standing position and whilst lying down. These gave a base value to review all other readings from. Readings were also taken in these positions whilst the subject was wearing a normal bra to see if this affected skin tension. The subject then wore a bra in accordance with the invention and uninflated inserts were inserted between the breast and bra. The insert comprised three bodies connected to one port which provided a single point of inflation. The insert also comprised one valve where a pressure gauge was inserted to take readings as the pressure was increased.
  • the inserts were shaped so that a portion sat just above the inframammary fold, i.e. just above the place where the breast and the chest meet, on the underside of the breast, with a side panel positioned at the side of the breast under the armpit, similar to the arrangement shown in Figure 9c.
  • Step 4 The inserts were inflated using an air pump. Inflation was undertaken in intervals, and the pressure and sensor readings noted at each stage, until either maximum pressure was reached, or the subject reported too much discomfort to continue. Four sensor readings were taken at each pressure interval and the values averaged.
  • CAD computer aided design
  • the model required a material to be assigned to the body, so the relevant properties of forces acting on the breast skin were applied as available in literature (shown in Table B).
  • Figure 4 shows the strain in the skin in the absence of a bra (standing naturally). The largest strain is shown in red and goes through to the lowest shown in dark blue. It can be seen that there is more strain above the nipple where the skin is working against gravity, in tension, to lift the breast tissue up and also in the inframammary fold under the breast tissue. This information is useful to understand the location of strain on the skin and the effect that pressure applied by an inflated insert(s) could have on reducing this strain. If the strain is reduced in the lower half of the breast, the forces which naturally pull apart a T-incision wound would be reduced and the wound tension will decrease. There is also a lot of strain working on the inframammary fold where the horizontal incision in the T wound is made.
  • the model was adapted to include an area where the inserts would apply pressure to the breast. Pressure was applied via the software to this area and increased through iterations. To measure the strain change, six points (A-F) were selected on the model so when the pressure in the inserts was increased, readings from each point could be taken to note the changes in strain. The six points are shown in Figure 5.
  • Figure 6 shows a graph of the strain of the skin against the pressure applied to the breast via the inserts at all six points.
  • the ideal pressure of the inserts was calculated at 649-77Pa using the steps set out in the mathematical model, above. Such a calculation is not an estimate of the pressure for the minimum skin tension, but how much pressure is needed to create a force that balances the weight of the breast.
  • Figure 7a shows more clearly the difference the pressure applied to the breast from inserts had at this fold.
  • the left breast shows the fold strain when there is no pressure in the inserts.
  • the right breast shows the strain of the skin when the inserts within the bra have a pressure of lsooPa.
  • the strain was clearly considerably less on the right at only 2.32 x lo ⁇ mm/mm.
  • the strain when no pressure was applied was maximum at point F for the entire breast, reaching three times the strain measured at its minimum.
  • Figure 7b also shows that the strain was least around the top edge where the insert applied pressure.
  • Points C, D, E, and F are on either side of the lower half of the breast, which is where pressure is applied to try and push the breast skin towards the centre of the breast at point D, at the location of the incision. This should reduce the tension at point D and therefore decrease the risk of the wound being pulled apart due to wound tension and decrease the healing time needed.
  • Figure 8a shows the relationships between points C, E and consequently D.
  • D has a minimum strain at a much lower pressure of 750Pa.
  • D generally has a higher tension throughout the simulation, which could be due to the curvature of the breast. It was situated at a point where there is a smaller radius than at the outer side points and the effect of the weight of the breast is maximum.
  • the strain at D had a range of 1.25 x lo ⁇ mm/mm.

Abstract

Le sein est une structure complexe et diverses forces mécaniques agissent et influencent la tension et la contrainte sur le tissu mammaire. Cette mécanique change avec des mouvements et des changements dans le sein, par exemple avec l'âge, l'activité, la chirurgie du sein, etc, qui peuvent altérer ou augmenter la tension de la peau et la contrainte sur le tissu mammaire. La présente invention concerne un soutien-gorge, en particulier pour une utilisation sportive ou post-chirurgicale, utilisant des inserts de formes, des pressions et des volumes variables pour négocier toute augmentation indésirable de la tension de la peau et de la contrainte sur le tissu mammaire. Il a été observé par modélisation mathématique et par des expériences, que la contrainte et les forces peuvent être contrées par la mise en place d'un ou de plusieurs inserts, à l'intérieur de poches intégrées à des emplacements stratégiques dans le soutien-gorge autour du sein, pour optimiser la tension de la peau. Le soutien-gorge innovant est équipé de poches pour insérer des inserts, des couches, des éléments de fixation et d'un mécanisme pour remplir, mesurer et ajuster la pression et le volume d'inserts aux besoins individualisés.
PCT/IN2021/050568 2020-06-12 2021-06-11 Soutien-gorge WO2021250703A1 (fr)

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GBGB2008963.7A GB202008963D0 (en) 2020-06-12 2020-06-12 A bra

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110065358A1 (en) * 2008-04-23 2011-03-17 Garth Fleeton Brassiere with inflation /deflation assembly
US20190328050A1 (en) * 2016-06-21 2019-10-31 Sheffield Hallam University Brassiere with inflatable bladder

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110065358A1 (en) * 2008-04-23 2011-03-17 Garth Fleeton Brassiere with inflation /deflation assembly
US20190328050A1 (en) * 2016-06-21 2019-10-31 Sheffield Hallam University Brassiere with inflatable bladder

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